EN 60580-2000 en Medical Electrical Equipment Dose Area Product Meters《医用电气设备 剂量面积仪 替代HD 379 S1-1979 IEC 60580 2000》.pdf

1、STDmBSI BS EN 60580-ENGL E!DOD m 1b24bb9 0857972 59T m BRITISH STANDARD Dose area product meters The European Standard EN 605802000 has the Status of a British Standard SEN 0580:ZOOO EC 605802000 ICs 11.040.60; 17.240 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGEl LAW STD.BSI BS

2、EN 60580-ENGL 2000 II Lh24bb 0857973 426 BS EN 60580:2000 been prepared under the direction of the Health and Environment Sector Committee, was published under the authority of the Standards Committee and comes into effect on 15 August 2000 Amd. No. O BSI 08-2000 ISBN O 580 34279 4 National foreword

3、 Date Comments This British Standard is the official English language version of EN 60580:2000. It is identical with IEC 605802000. The UK participation in its preparation was entrusted to Technical Committee CW, Dosemeters (medical), which has the responsibility to: - aid enquirers to understand th

4、e text; - present to the responsible internationaYEuropean committee any enquiries on the interpretation, or proposais for change, and keep the UK interests informed; - monitor related international and European developments and promulgate them in the UK A list of organizations represented on this c

5、ommittee can be obtained on request to its secretary Flom 1 January 1997, all JEC publications have the number 60000 added to the old number. For instance, IEC 27-1 has been renumbered as IEC 60027-1. For a period of time during the change over from one numbering system to the other, publications ma

6、y contain identifers from both systems. Cross-references Attention is drawn to the fact that CEN and CENELEC Standards normally include an annex which lits normative references to international publications with their corresponding European publications. The British Standards which implement these i

7、nternational or European publications may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include all the necessary pro

8、visions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, the EN title page, pages 2 to

9、34, an inside back cover and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. STD=BSI BS EN bDSAO-ENGL ZOO0 Lb24bb9 0857974 362 EUROPEAN STANDARD NORME EUROPEENNE EUROPAISCHE NORM EN 60580 May 2000 ICs 11 .WOSO Supersedes HD 379 S1:1979 E

10、nglish version Medical electrical equipment Dose area product meters (I EC 60580:2000) Appareils lectromdicaux Medizinische elektrische Gerte Radiamtres de produit exposition-surface Dosisflchenprodukt-Messgerte (CE1 60580:2000) (IEC 60580:2000) This European Standard was approved by CENELEC on 2000

11、-02-01. CENELEC members are bound to comply with the CENICENELEC Internal Regulations which stipulate the conditions for gMng this European Standard the status of a national standard without any alteration. Uptodate lists and bibliographical references concerning such national standards may be obtai

12、ned on application to the Central Secretariat or to any CENELEC member. This European Standard exists in three offiaal versions (English, French, German). A version in any other language made by translation under the responsibility of a CENELEC member into its own language and notied to the Central

13、Secretariat has the same status as the official versions. CENELEC members are the national electrotechnical committees of Austria, Belgium, Ctech RepuMc, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and Unit

14、ed Kingdom. CENELEC European Committee for Electmtechnical Standardization Comit Europen de Normalisation Electrotechnique Europaisches Komitee fr Elektrotechnische Normung Cental Secretariat: rue e Stassart 35, B - 1050 Bntsseis Q 2000 CENELEC - Ail rights of exploitation in any form and by any mea

15、ns reserved worldwide for CENELEC members. Ref. No. EN 60580:2000 E STD*BSI BS EN 60580-ENGL 2000 Lb24667 0857775 2TY m Page 2 EN 60580:2000 Foreword The text of document 62C/272/FDISl future edition 1 of IEC 60580, prepared by IEC TC 62, Electrical equipment in medical practice, was submitted to th

16、e IEC-CENELEC parallel vote and was approved by CENELEC as EN 60580 on 2000-02-01. This European Standard supersedes HD 379 SI : 1979. The following dates were fixed: - latest date by which the EN has to be implemented at national level by publication of an identical national standard or by endorsem

17、ent (dop) 2000-1 1-01 - latest date by which the national standards conflicting with the EN have to be withdrawn (dow) 2003-02-01 Annexes designated “normative“ are part of the body of the standard. In this standard, annex ZA is normative. Annex ZA has been added by CENELEC. Endorsement notice The t

18、ext of the International Standard IEC60580:2000 was approved by CENELEC as a European Standard without any modification. STD-BSI BS EN bO58O-ENGL 2000 1624669 085797b 135 Page 3 EN 60580:2000 CONTENTS Page INTRODUCTION 5 Clause 1 Scope and object . 7 2 Normative references . 7 3 Terminology and defi

19、nitions . 8 4 General requirements 14 4.1 Performance requirements 14 Plane of measurement 14 REFERENCE VALUES and STANDARD TEST CONDITIONS 14 General test conditions . 14 4.5.1 STANDARD TEST CONDITIONS 14 4.5.2 4.5.3 STABILIZATION TIME . 15 4.5.4 Adjustments during test . 15 4.5.5 4.6 Statistical f

20、luctuations . 15 4.7 Uncertainty of measurement 15 4.8 Indication of polarizing voltage failure 16 4.8.3 Over-ranging . 16 4.8.5 IONIZATION CHAMBER . 17 STABILITY CHECK DEVICE . 17 4.10 Adjustment . 17 Limits Of PERFORMANCE CHARACTERISTICS under STANDARD TEST CONDITIONS . 18 5.1 RELATIVE INTRINSIC E

21、RROR 18 5.2 Warning function . 18 5.3 Repeatability . 19 5.4 RESOLUTION Of reading . 19 5.5 STABILIZATION TIME . 19 5.6 Reset on DOSE AREA PRODUCT ranges 19 5.7 Drift Of INDICATED VALUES . 19 5.8 5.9 RESPONSE TIME 20 5.1 O Spatial uniformity of RESPONSE 20 4.2 Minimum EFFECTIVE RANGES Of DOSE AREA P

22、RODUCT and DOSE AREA PRODUCT RATE 14 4.3 4.4 4.5 Test of components . 14 Uniformity of radiation field 15 Constructional requirements as related to performance 16 4.8.1 Display 16 4.8.2 4.8.4 Indication of reset or other inactive condition . 16 4.9 4.1 1 Electrical safety 18 5 Long term stability 20

23、 O BSI 08-2000 STD.BSI BS EN hO58O-ENGL 2000 = 1624669 0857977 071 Page 4 EN 60580:2000 Clause Page 6 LIMITS OF VARIATION for effects Of INFLUENCE QUANTITIES . 21 6.1 Energy dependence of RESPONSE 21 6.2 DOSE AREA PRODUCT RATE dependence Of DOSE AREA PRODUCT meaSUementS . 21 6.2.1 MEASURING ASSEMBLY

24、 . 21 6.2.2 IONIZATION CHAMBER - Recombination loSSes 22 6.3 IRRADIATION TIME . 22 6.4 Field size 22 6.5 Operating voltage . 22 6.6 Air pressure 23 6.7 Temperature and humidity . 23 6.8 Air density fluctuation in the IONIZATION CHAMBER . 23 6.9 Electromagnetic compatibility 23 6.9.1 General . 23 6.9

25、.2 Electrostatic discharge 24 6.9.3 Radiated electromagnetic fields . 24 6.9.4 Conducted disturbances induced by bursts and high frequencies 24 6.9.5 Surges 25 6.9.6 Voltage dips, short interruptions and voltage VARIATIONS 25 7 Marking . 25 6.10 COMBINED STANDARD UNCERTAINTY 25 7.1 MEASURING ASSEMBL

26、Y . 25 7.2 IONIZATION CHAMBER 26 8 ACCOMPANYING DOCUMENTS . 26 Table I . Minimum EFFECTIVE RANGES 27 Table 2 - REFERENCE VALUES and STANDARD TEST CONDITIONS 27 Table 3 - Number of readings required to detect true differences A (95 % confidence level) between two sets of instrument readings 28 Table

27、4 - RELATIVE INSTRINSIC ERROR, I 28 Table 5 - Maximum Values for the COEFFICIENT OF VARIATION, v, 28 Table 6 - LIMITS OF VARIATION for the effects Of INFLUENCE QUANTITIES 29 Table 7 - Example for aSSeSSment Of the COMBINED STANDARD UNCERTAINTY 30 Bibliograph y . 31 Index of defined terms 32 Annex ZA

28、 (normative) Normative references to international publications with their corresponding European publications . 33 O BSI 08-2000 STD-BSI BS EN bOSO-ENGL 2000 1624669 0857978 TO8 Page 6 EN 60680:2000 INTRODUCTION Diagnostic radiology is the largest contributor to man-made ionizing radiation to which

29、 the public is exposed. The reduction in the exposure received by PATIENTS undergoing MEDICAL RADIOLOGICAL EXAMINATIONS or procedures has therefore become a central issue in recent years. The purpose of routine measurement of DOSE AREA PRODUCT is to help in achieving an overall reduction in the radi

30、ation received by PATIENTS undergoing MEDICAL RADIOLOGICAL EXAMINATIONS. Provided adequate records are kept, it is possible to determine patient doses, to compare different examination techniques, to establish a technique giving minimum radiation to a PATIENT, and to ensure a maintenance of that tec

31、hnique; in this respect, such measurements have a place of particular importance in training establishments. Examination of records may also indicate a deterioration in the efficiency of the image-production system. special requirements laid down in this International Standard. DOSE AREA PRODUCT MET

32、ERS must be Of Satisfactory qUalty and mUSt therefore fulfil the O BSI 08-2000 Page 6 EN 60580:2000 MEDICAL ELECTRICAL EQUIPMENT - DOSE AREA PRODUCT METERS 1 Scope and object This International Standard specifies the performance and testing of DOSE AREA PRODUCT METERS With IONIZATION CHAMBERS intend

33、ed to measure DOSE AREA PRODUCT and/or DOSE AREA PRODUCT RATE to which the PATIENT is exposed during MEDICAL RADIOLOGICAL EXAMINATIONS. The object of this International Standard is 1) to establish requirements for a satisfactory level of performance for DOSE AREA PRODUCT 2) to standardize the method

34、s for the determination of compliance with this level of METERS, and pe rfo r rn a n ce. 2 Normative references The following normative documents contain provisions which, through reference in this text, constitute provisions of this International Standard. For dated references, subsequent amendment

35、s to, or revisions of, any of these publications do not apply. However, parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition

36、 of the normative document referred to applies. Members of IEC and IS0 maintain registers of currently valid International Standards. IEC 6041 7 (all parts), Graphical symbols for use on equipment IEC 60601 -1 :I 988, Medical electrical equipment - Part I: General requirements for safety IEC 60601-1

37、-1 :I 992, Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems IEC 60601-1-2:1993, Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibil

38、ity - Requirements and tests IEC 60731 :I 997, Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy IEC 60788:1984, Medical radiology - Terminology IEC 60950: 1999, Safety of information technology equipment IEC 61 000-4-2:1995, Electromagnetic compatibility (EM

39、C) - Part 4-2: Testing and measure- ment techniques - Electrostatic discharge immunity test IEC 61 000-4-3: 1995, Electromagnetic compatibility (EMC) - Part 4-3: Testing and measure- ment techniques - Radiated, radio-frequency, electromagnetic field immunity test 1) 1) There exists a consolidated ed

40、ition 1.1 (1998) that includes IEC 61000-4-3 (1995) and its amendment 1 (1998). BCI 08-2000 STD-BSI BS EN bOS8O-ENGL ZOO0 W Lb24bb7 0857780 bbb Page 7 EN 60680:2000 IEC 61 000-4-4:1995, Electromagnetic compatibility (EMC) - Part 4-4: Testing and measure- ment techniques - Electrical fast transienbur

41、st immunity test IEC 61 000-4-51995, Electromagnetic compatibility (MC) - Part 4-5: Testing and measure- ment techniques - Surge immunity test IEC 61 000-4-6: 1996, Electromagnetic compatibility (EMC) - Part 4-6: Testing and measure- ment techniques - Immunity to conducted disturbances induced by ra

42、dio frequency fields IEC 61000-4-1 1 :1994, Electromagnetic compatibility (EMC) - Part 4-1 1: Testing and measure- ment techniques - Voltage dips, short interruptions and voltage variations immunity tests IEC 61 187:1993, Electrical and electronic measuring equipment - Documentation ICRU 60: 1998, I

43、nternafional Commission on Radiation Units and Measurements, fundamental Quantities and Units for Ionizing Radiation, Report 60, CRU Publications, Bethesda MD (1 998) ISO, Internafional Organization for Standardization, International vocabulary of basic and general terms in metrology, 2“d edition, G

44、eneva (1993) ISO, International Organization for Standardization, Guide to the expression of uncertainty in measurement, 1“ edition, Geneva (1993) 3 Terminology and definitions In this International Standard the auxiliary verb - “shall“ implies that compliance with a requirement is mandatory for com

45、pliance with the standard; - “may“ implies that compliance with a requirement is permitted to be accomplished in a particular manner for compliance with the standard. The definitions given in this International Standard are generally in agreement with those in IEC 60788 and ISO: International vocabu

46、lary of basic and general terms in metrology; uncertainties are evaluated in accordance with ISO: Guide to the expression of uncertainty in measurement, Terms not defined in this subclause or listed in the index of defined terms have the meanings defined in the above publications or are assumed to b

47、e terms of general scientific usage. An alphabetical list of defined terms is given in the index. For the purposes of this International Standard the following definitions apply: 3.1 ACCOMPANYING DOCUMENTS documents provided with an installation, equipment, associated equipment or accessory, contain

48、ing important information for the assembler, installer and user, particularly regarding safety O BSI 08-2000 STD-BSI BS EN b0580-ENGL 2000 E 3b24bb9 0857983 5T2 Page 8 EN 60580:2000 3.2 AIR KERMA (Letter symbol K) quotient of dtr by dm, where dEt, is the sum of the initial kinetic energies of all th

49、e charged particles in a mass dm of air, thus K=- dftr dm Unit: J kg-1 The special name for the unit of AIR KERMA is gray (Gy) (ICRU 60) 3.3 quotient of dK by dt, where dK is the increment of AIR KERMA in the time interval dt, thus AIR KERMA RATE (Letter symbol k) Unit: J kg-1 s-1 If the special name gray is used, the unit Of AIR KERMA rate is gray per 3.4 COEFFICIENT OF VARIATION standard deviation of a set of readings expressed as a percentage readings second (Gy s-1) (ICRU 60) of the mean value of these 3.5 value used instead of the TRUE VALUE when calibrating